Align site Risk Management practices with Pfizer standards and Regulatory Guidance documents. Work with teams of SME colleagues to complete risk assessments. Develop and maintain risk assessment tools and infrastructure to address emerging compliance and organizational needs.• Facilitate risk assessment to assure compliance to both Pfizer and Regulatory standards. • Provide guidance and direction to QRM teams and leaders to assure consistent application of risk assessment principles. • Design and implement risk assessment tools to address full range of emerging needs and applications. • Maintain QRM/risk assessment library and other databases, including lifecycle management of approved QRMs.

Develops and implements global strategic plans for Risk Management to include the identification of operational risks and associated mitigations. Manage non-conformances and corrective action processes (CAPA).• Develop and implement a global risk management process.• Consolidated and developed nonconformance and corrective action metrics.

Creates and implements policies and procedures which result in attaining quality goals and GxP globally. Provide direction and leadership to global personal regarding operational compliance to all applicable federal and local guidelines.• Set goals for performance, monitors employee productivity and provides constructive feedback and coaching.• Manage CAPA and Risk Management processes and improve processes to reduce waste and reduce complexity for sample handling and laboratory services.• Manage customer complaint handling and non-conformance investigations. • Lead sample handling and laboratory processes risk assessments to identify and mitigate risks.• Lead and participate in client audits, supplier audits, and internal audits.

Creates and implements policies and procedures which result in attaining quality goals and GxP globally. Provide direction and leadership to global personal regarding operational compliance to all applicable federal and local guidelines.• Manage CAPA and Risk Management processes and improve processes to reduce waste and reduce complexity for sample handling and laboratory services.• Manage customer complaint handling and non-conformance investigations. • Lead sample handling and laboratory processes risk assessments to identify and mitigate risks.• Lead and participate in client audits, supplier audits, and internal audits.

• Managed Risk Assessment for medical device product development, product improvement projects, and complaint investigations for five global sites.• Managed CAPA Program for medical devices for three global sites.• Managed quality system for ISO 17025 Accreditation and sustainment• Supported new product development of medical devices, both hardware and reagent, to bring products to market.• Led ISO 9001, ISO 13485, ISO 14971, and ISO 17025 internal audits. Worked with auditee in developing and implementing corrective actions.• Investigated and trended customer complaints.

• Independently planned, coordinate, and develop product quality documentation,• Represented quality assurance on product development and product improvement projects• Provided design review and risk management of product development and product improvement projects• Approved product design documents, implementation plans, and verification protocols.• Reviewed, implemented, or revised product project, and program activities

BECKMAN COULTER, INC. Indianapolis, Indiana 2010-2011(Contracted Senior Quality Assurance Engineer through Adecco Engineering and Technical)Senior Quality Assurance Engineer• Independently planne, coordinate, and develop product quality documentation.• Represented quality assurance on product development and product improvement projects.• Provided design review and risk management of product development and product improvement projects.• Approved product design documents, implementation plans, and verification protocols.

(Contracted Quality Assurance personnel through Aerotek Scientific LLC)Reviewed documentation for compliance to cGMPs (Master Batch Records, SOPs, Validation Protocols, Non-Conformance reports, Microbiology investigations, and Laboratory investigations); and provides recommendations and implements process improvements. • Reviewed manufacturing batch records to ensure compliance to cGMPs and the safety and reliability of Baxter products. • Performed final batch disposition.• Initiated and confirmed Non-Conformance reports and participated in the investigation and writing as required. • Provided customer service (batch status updates, issue resolution, data inquiries, etc.) to internal and external customers. • Actively participated in an environment of teamwork and communication between Quality Assurance and Production to ensure on-time Quality review of manufacturing batch records.

Managed team to ensure compliance to FDA and corporate quality, engineering and maintenance requirements; qualification and validation of equipment and software; corrective and preventive actions; manage and participate in audits; and approve procedures and vendors. Manage ISO Quality System of an ISO17025 Accredited Metrology Lab.